Mifepristone Side Effects

Not all side effects for mifepristone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to mifepristone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by mifepristone. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking mifepristone:

Less common

Excessively heavy vaginal bleeding

unusual tiredness or weakness

Incidence not known

Chest pain or discomfort

confusion

cough or hoarseness

fast, weak pulse

fever or chills

lower back or side pain

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pale, cold, or clammy skin

shortness of breath

sudden increase in stomach or shoulder pain

sweating

unusual or large amount of vaginal bleeding

Some of the side effects that can occur with mifepristone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common

Abdominal or stomach pain or uterine cramping

back pain

diarrhea

dizziness

headache

nausea or vomiting

Less common

Acid or sour stomach

anxiety

belching

cough

fainting or lightheadedness when getting up from a lying or sitting position

fever

flu-like symptoms

headache

heartburn

increased clear or white vaginal discharge

indigestion

itching of the vagina or genital area

lack or loss of strength

pain during sexual intercourse

pain or tenderness around the eyes and cheekbones

pale skin

shaking chills

shortness of breath or troubled breathing

sleeplessness or trouble sleeping

stomach discomfort, upset, or pain

stuffy or runny nose

tightness of the chest or wheezing

troubled breathing, exertional

unusual bleeding or bruising

For Healthcare Professionals

Applies to mifepristone: oral tablet

Hematologic

Hematologic side effects have included anemia and a decrease in hemoglobin of greater than 2 g/dL in 2% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (96%), nausea (43% to 61%), vomiting (2% to 31%), diarrhea (18% to 26%), and dyspepsia (3%). Additional side effects in patients with Cushing syndrome included decreased appetite, dry mouth, and constipation.[Ref]

Nervous system

Nervous system side effects have included headache (2% to 31%), dizziness (1% to 12%), fatigue (10%), insomnia (3%), asthenia (3%), and fainting (2%). Postmarketing reports have included reports of light headedness and loss of consciousness. Additional side effects in patients with Cushing syndrome included somnolence.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain (9%) and leg pain (2%). Additional side effects in patients with Cushing syndrome included arthralgia, myalgia, and pain in extremity.[Ref]

Immunologic

Immunologic side effects have included fever (4%) and viral infections (4%).[Ref]

Psychiatric

Cardiovascular

Cardiovascular side effects have included syncope (1%). Postmarketing reports have included tachycardia (including racing pulse, heart palpitations, and pounding heart. Hypotension, including orthostatic hypotension, has also reported in after marketing use. Additional side effects in patients with Cushing syndrome included hypertension and peripheral edema.[Ref]

Respiratory

Respiratory side effects have included sinusitis (2%). Additional side effects in patients with Cushing syndrome included nasopharyngitis and dyspnea.[Ref]

Hypersensitivity

Hypersensitivity side effects have included shortness of breath, rash, hives and itching.[Ref]

General

General side effects in patients with Cushing syndrome included pain and fatigue.[Ref]

Professional resources

Related treatment guides

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